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Careers US

Northway Biotech is expanding to the US and opening a new facility in Waltham, Greater Boston area of Massachusetts, one of the major biotechnology hubs.

About Us

Northway Biotech is constantly looking for enthusiastic and ambitious team players who dedicate their talents to improve and produce biopharmaceuticals. Through highly skilled leadership we provide you the opportunity to use and develop your competencies to their full potential. As well as improve knowledge and skills together with inspiring colleagues.

Working at Northway Biotech means interacting with intelligent and empowered people who focus on emerging technologies that are ground-breaking, exciting, and have a positive impact on humankind. If this sounds like a place you would like to work at, we invite you to apply for one of the listed positions below. Send us your life resume and cover letter via cv@northwaybiotech.com

 

 

 

Vacancies


Analytical Development Senior/Principal Research Associate

Job Description

  • Perform development, execution, troubleshooting, and analysis of liquid chromatography based testing with minimal supervision.
  • Responsible for assay optimization, qualification, and validation, and technology transfer for proteins and other biomolecules.
  • Execute, develop, and troubleshoot assays such as ELISA, CE, gel electrophoresis and Western
  • Perform cell-based assays (e.g. flow cytometry) if needed.
  • Support upstream and downstream process development in-process testing, product release testing, and stability study testing.
  • Generate, manage, evaluate, and maintain data in a highly organized manner.
  • Coordinate with cross-functional departments on various projects.
  • Interpret data and contribute to technical reports.
  • Identify technical issues and implement solutions.
  • Ensure high-quality, timely documentation in laboratory notebooks and technical reports.

Requirements

  • BS/MS in Biochemistry, Molecular Biology, Cell Biology, Immunology, or related fields.
  • 5 - 10 years’ of experience in the pharmaceutical industry in protein/biomolecule characterization assays and immunoassays.
  • Proficiency and experience in analytical techniques (HPLC, SDS-PAGE, Western etc.)
  • Familiarity with protein/biomolecule assay development, optimization, qualification, and validation is required.
  • Familiarity with CE, ELISA, LC/MS and data analysis desired but not required.
  • Experience with cell-based assay for release and characterization is a plus.
  • Familiar with statistical and data analysis tools, such as JMP, Prism etc. will be a plus.
  • Ability and desire to work in a fast-paced, start-up environment.
  • Strong collaboration, team-working, documentation, and communication skills.
  • Independently motivated and detail-oriented with good problem-solving ability.
  • Must be able to work effectively in cross-functional teams.

 

Downstream Process Development Engineer

Job Description

  • Perform hands-on execution of all aspects of purification, filtration, and formulation activities to develop scalable and robust downstream processes.
  • Prepare reagents, components, buffers and other solutions. Maintain equipment and raw materials/consumables inventory to ensure smooth operation.
  • Conduct purification and filtration experiments to support small-scale studies, process scale-up, technology transfer and process optimization.
  • Complete in-process analytical testing for downstream process development studies.
  • Coordinate with cross-functional departments on various projects. Interpret data and contribute to technical reports.
  • Identify technical issues and implement solutions.
  • Ensure high-quality, timely documentation in laboratory notebooks and technical reports.

Requirements

  • BS degree in Biology, Biochemistry, Chemistry, Chemical Engineering or equivalent. 5 - 10 years’ experience in recombinant protein or biomolecule purification development.
  • Good understanding of protein chemistry, protein analytics and bioprocess technology is required.
  • Understanding chromatography modalities such as anion/cation exchange, hydrophobic interaction, affinity, and multimodal chromatography.
  • Experience operating and troubleshooting downstream unit operations (Columns, UF/DF, TFF, VI, and VF).
  • Analytical assay experience (SDS PAGE and agarose gel electrophoresis, protein and DNA concentration determinations, and immunoassays) is a plus.
  • Ability and desire to work in a fast-paced, start-up environment.
  • Strong collaboration, team-working, documentation, and communication skills.
  • Independently motivated and detail-oriented with good problem-solving ability.
  • Must be able to work effectively in cross-functional teams.

 

Quality Assurance Senior Manager/Associate Director

Job Description

  • Plan, coordinate, and direct quality control program designed to ensure continuous production of products consistent with established standards. Develop and analyze statistical data and product specifications to determine present standards and establish proposed quality and reliability expectancy of finished biologics product.
  • Formulate and maintain quality control objectives and coordinate objectives with production procedures in cooperation with other plant managers to maximize product reliability and minimize costs.
  • Achieve quality assurance operational objectives by contributing information and analysis to strategic plans and reviews; preparing and completing action plans; implementing production, productivity, quality, and customer-service standards; identifying and resolving problems; completing audits; determining system improvements; implementing change.
  • Develop quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures; monitoring inventories.
  • Validate quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification; writing and updating quality assurance procedures.
  • Maintain and improve product quality by completing product, company, system, compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop new product and engineering designs, and manufacturing and training methods.
  • Prepare quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Responsible for ensuring a product or service meets the established standards of quality including reliability, usability and performance required for distribution and the market.

Requirements

  • Minimum of Bachelor’s degree in a scientific discipline.
  • 5 – 10 years industry QA experience including managing GXP quality systems in the Pharma/Biotech industry.
  • Extensive knowledge of cGMP and ICH requirements for biologics development and manufacturing, including drafting, interpreting, and implementing quality assurance policies and procedures as well as establishing document management activities.
  • Significant experience with establishing QMS solutions (especially for a multi-client environment), supporting on-site audits, and ensuring finished product quality.
  • Ability to independently assess R&D and manufacturing activities for compliance to regulatory standards for cGMPs, identify areas of non-compliance, recommend corrective action, as well as participate or lead team-based solutions.
  • Demonstrated management/supervisory experience, with a history of developing a culture of teamwork, collaboration, and ability to advance group goals to meet company objectives.
  • Experienced, self-motivated individual who can handle multiple priorities to meet project team goals and timelines.
  • Excellent communicator with strong leadership, presentation and influencing skills, and problem-solving ability.
  • Experience in managing relationships with internal departments, external vendors, and clients in a collaborative manner.
  • Excellent written and verbal skills and the ability to communicate clearly, concisely, and effectively.
  • Proficiency with MS Office, MS Project, PowerPoint and SharePoint

 

Recruitment


Northway Biotech will process and store your personal data on your consent expressed by submitting this information. We process this data for recruitment purposes only. We will store such information until the position is open, unless you specifically agree with longer storage periods.

When evaluating your candidacy, we may address your former employers for information about your qualifications, professional skills, and business characteristics. Information from your current employer may only be collected with your consent.

If, after considering your candidacy, we will choose a candidate who is more qualified to meet our requirements, we may request your individual consent for storing your data collected at the time of selection and use it for the purpose of conducting other recruitments and contacting you accordingly.

If we obtain such consent, we will process your personal data mentioned above for no longer than two years from the date of consent. Once you have provided such consent, you are entitled to withdraw it at any time. If you exercise the right to withdraw consent, we will take actions to delete your personal data without any undue delay.

For all inquiries and complaints regarding the security and privacy of your data please contact our Data Protection Officer at cv@northwaybiotech.com